Patient Assistance Related Functions. 1) Amgen’s systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. This review shall include an assessment of the following: a. Amgen’s organizational structure as it relates to arrangements and interactions with Independent Charity PAPs, including: i. the identification of those individuals, departments, or groups within Amgen (e.g., the PAP Governance Committee, legal, compliance) that have responsibility for, or involvement with, such arrangements and interactions; ii. the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs; iii. the identification of those individuals, departments, or groups within Amgen (e.g., the commercial business units) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and iv. methods that Amgen uses to separate Independent Charity PAP- related responsibilities from the commercial business units. b. Amgen’s written policies and procedures as they relate to arrangements and interactions with Independent Charity PAPs, including: i. the criteria governing whether and under what circumstances Amgen would donate to an Independent Charity PAP or any specific disease state fund of such a PAP; ii. communications (including any limitations on such communications) between any representatives of Amgen and any Independent Charity PAP (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications including the exchange of any data); iii. communications (including any limitations on such communications) between those individuals, departments, or groups within Amgen with responsibility for Independent Charity PAPs and the commercial business units of Amgen (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications); and iv. communications (including any limitations on such communications) between representatives of Amgen and health care providers or patients regarding assistance available through any Independent Charity PAP. c. ▇▇▇▇▇’s policies and practices as they relate to the budgeting process applicable to donations to Independent Charity PAPs as outlined in Section III.J.2 of the CIA, including as it relates to initial or annual donation amounts and any supplemental amounts; d. Amgen’s policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to donate (or continue to donate) to a particular Independent Charity PAP; and ii) the amount of the donation (including any initial or annual amount and any supplemental amount); e. Amgen’s policies and practices as they relate to donations made by Amgen to any Independent Charity PAPs as referenced in Section III.J.3, including the internal review process followed in connection with any donations to Independent Charity PAPs; and f. Amgen’s policies and practices as they relate to information provided, directly or indirectly, to the public about the availability of patient assistance for Amgen’s products. 2) Amgen’s systems, policies, processes, and procedures relating to any Amgen PAPs. This review shall include an assessment of the following: a. The general elements of Amgen PAPs, including: i) the types of assistance that are made available through Amgen PAPs; ii) the types of patients to whom each type of assistance is made available; iii) the eligibility criteria for the various types of assistance provided; and iv) the controls used to implement the eligibility criteria (i.e., controls employed to ensure that appropriate patients receive the various types of assistance). b. Amgen’s policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to provide (or continue to provide) the various types of assistance through any Amgen PAP; and ii) the amount (or value) of the assistance to be provided through each program (including any initial or annual amount and any supplemental amount); and c. Amgen’s policies and practices as they relate to any contracts or agreements entered between Amgen and outside entities relating to any Amgen PAPs or the distribution of free product, including the individuals, groups, or departments involved in the negotiation process, the requirements and terms of the contracts or agreements, and the review and approval of such contracts or agreements.
Appears in 1 contract
Sources: Corporate Integrity Agreement
Patient Assistance Related Functions.
1) AmgenPfizer’s systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs. This review shall include an assessment of the following:
a. AmgenPfizer’s organizational structure as it relates to arrangements and interactions with Independent Charity PAPsPAPS, including:
i. the identification of those individuals, departments, or groups within Amgen Pfizer (e.g., the PAP Governance CommitteeIndependent Charity Group, legal, compliance) that have responsibility for, or involvement with, such arrangements and interactions;
ii. the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs;
iii. the identification of those individuals, departments, or groups within Amgen Pfizer (e.g., the commercial business units) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and
iv. methods that Amgen Pfizer uses to separate Independent Charity PAP- related responsibilities from the commercial business units.
b. AmgenPfizer’s written policies and procedures as they relate to arrangements and interactions with Independent Charity PAPs, including:
i. the criteria governing whether and under what circumstances Amgen Pfizer would donate to an Independent Charity PAP or any specific disease state fund of such a PAP;
ii. communications (including any limitations on such communications) between any representatives of Amgen Pfizer and any Independent Charity PAP (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications including the exchange of any data);
iii. communications (including any limitations on such communications) between those individuals, departments, or groups within Amgen Pfizer with responsibility for Independent Charity PAPs and the commercial business units of Amgen Pfizer (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications); and
iv. communications (including any limitations on such communications) between representatives of Amgen Pfizer and health care providers or patients regarding assistance available through any Independent Charity PAP.
c. ▇▇▇▇▇Pfizer’s policies and practices as they relate to the budgeting process applicable to donations to Independent Charity PAPs as outlined in Section III.J.2 III.J.3 of the CIA, including as it relates to initial or annual donation amounts and any supplemental amounts;
d. AmgenPfizer’s policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to donate (or continue to donate) to a particular Independent Charity PAP; and ii) the amount of the donation (including any initial or annual amount and any supplemental amount);
e. AmgenPfizer’s policies and practices as they relate to donations made by Amgen Pfizer to any Independent Charity PAPs as referenced in Section III.J.3III.J.4, including the internal review process followed in connection with any donations to Independent Charity PAPs; and
f. AmgenPfizer’s policies and practices as they relate to information provided, directly or indirectly, to the public about the availability of patient assistance for AmgenPfizer’s products.
2) AmgenPfizer’s systems, policies, processes, and procedures relating to any Amgen Pfizer PAPs. This review shall include an assessment of the following:
a. The general elements of Amgen Pfizer PAPs, including: i) the types of assistance that are made available through Amgen Pfizer PAPs; ii) the types of patients to whom each type of assistance is made available; iii) the eligibility criteria for the various types of assistance provided; and iv) the controls used to implement the eligibility criteria (i.e., controls employed to ensure that appropriate patients receive the various types of assistance).assistance);
b. AmgenPfizer’s policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to provide (or continue to provide) the various types of assistance through any Amgen Pfizer PAP; and ii) the amount (or value) of the assistance to be provided through each program (including any initial or annual amount and any supplemental amount); and
c. AmgenPfizer’s policies and practices as they relate to any contracts or agreements entered between Amgen Pfizer and outside entities relating to any Amgen Pfizer PAPs or the distribution of free product, including the individuals, groups, or departments involved in the negotiation process, the requirements and terms of the contracts or agreements, and the review and approval of such contracts or agreements.
Appears in 1 contract
Sources: Corporate Integrity Agreement